U.S. patent number 10,307,144 [Application Number 14/615,786] was granted by the patent office on 2019-06-04 for suture delivery device for suturing tissue.
This patent grant is currently assigned to MEDEON BIODESIGN, INC.. The grantee listed for this patent is MEDEON BIODESIGN, INC.. Invention is credited to Shuling Cheng, Eric Y. Hu, Po-Hua Lee, Hsiao-Wei Tang, I-Ching Wu.
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United States Patent |
10,307,144 |
Wu , et al. |
June 4, 2019 |
Suture delivery device for suturing tissue
Abstract
Systems are provided for delivering a suture to close a surgical
opening. An elongated deployment member may have at its distal end
a retracted counterforce member. The counterforce member may be
inserted into the surgical opening and deployed to resist being
withdrawn from the opening. A compression member may be slid down
the elongated member to compress the tissue to be sutured against
the counterforce member. Suture passers loaded with suture ends may
be passed through needle tubes within the elongated member to
emerge from the elongated member and pierce the tissue to be
sutured, then deposit the suture ends with a suture catcher. The
suture passers may be withdrawn, leaving the suture ends. The
suture catcher may be retracted, retaining the suture ends and the
device--elongated member, retracted suture catcher, and retained
suture end--may be withdrawn from the surgical opening. The suture
may then be completed.
Inventors: |
Wu; I-Ching (Los Altos, CA),
Hu; Eric Y. (Los Altos, CA), Lee; Po-Hua (Los Altos,
CA), Tang; Hsiao-Wei (Taipei, TW), Cheng;
Shuling (Taipei, TW) |
Applicant: |
Name |
City |
State |
Country |
Type |
MEDEON BIODESIGN, INC. |
Taipei |
N/A |
TW |
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Assignee: |
MEDEON BIODESIGN, INC. (Taipei,
TW)
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Family
ID: |
53773907 |
Appl.
No.: |
14/615,786 |
Filed: |
February 6, 2015 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20150223804 A1 |
Aug 13, 2015 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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61937089 |
Feb 7, 2014 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B
17/0482 (20130101); A61B 17/0057 (20130101); A61B
17/0625 (20130101); A61B 2017/00663 (20130101); A61B
2017/00637 (20130101) |
Current International
Class: |
A61B
17/00 (20060101); A61B 17/04 (20060101); A61B
17/062 (20060101) |
Field of
Search: |
;606/144,148 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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2412317 |
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Feb 2012 |
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EP |
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2010081106 |
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Jul 2010 |
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WO |
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Other References
International Searching Authority, Notification of Transmittal of
the International Search Report and the Written Opinion of the
International Search Authority, PCT/US2015/014797, dated May 7,
2015, pp. 1-9. cited by applicant .
Supplementary European Search Report and Written Opinion for
European Application No. 15746966.9, dated Nov. 17, 2017. cited by
applicant .
International Search Report and Written Opinion for PCT Application
No. PCT/US17/46347; dated Nov. 28, 2017. cited by
applicant.
|
Primary Examiner: Ton; Martin T
Attorney, Agent or Firm: Dergosits & Noah LLP Noah; Todd
A.
Parent Case Text
RELATED APPLICATIONS
This application claims priority to and benefit of U.S. Provisional
Patent Application Ser. No. 61/937,089, filed Feb. 7, 2014, the
contents of which are incorporated by reference in its entirety.
Claims
What is claimed is:
1. A suture delivery device for suturing tissue comprising: an
elongated deployment member; a counterforce member disposed towards
a distal end of the elongated deployment member, wherein the
counterforce member is configured to transition between a retracted
configuration that facilitates the counterforce member entering an
incision and a deployed configuration that resists extracting the
counterforce member from an incision; a compression member disposed
towards a proximal end of the elongated deployment member with
respect to the counterforce member, wherein the compression member
is configured to resist entering an incision, and wherein the
compression member and the counterforce member transitions between
a compressed configuration and an uncompressed configuration; a
suture catcher disposed towards the distal end of the elongated
deployment member, wherein the suture catcher is configured to
transition between a retracted configuration that facilitates the
suture catcher entering an incision and a deployed configuration
that facilitates catching a suture; a first needle track extending
through the compression member and oriented to direct a needle
advanced through the first needle track into engagement with a
first area of the suture catcher when in the deployed
configuration; and a second needle track extending through the
compression member and oriented to direct a needle advanced through
the second needle track into engagement with a second area of the
suture catcher when in the deployed configuration, wherein the
first area of the suture catcher when in the deployed configuration
and the second area of the suture catcher when in the deployed
configuration are situated on the suture catcher to allow their
placement on opposite sides of an incision.
2. The suture delivery device of claim 1, wherein in the compressed
configuration the compression member is at a first distance from
the counterforce member and in the uncompressed configuration the
compression member is at a second distance from the counterforce
member, the first distance being less than the second distance.
3. The suture delivery device of claim 2, wherein the compression
member is moved in transitioning between the compressed
configuration and the uncompressed configuration.
4. The suture delivery device of claim 2, wherein the counterforce
member is moved in transitioning between the compressed
configuration and the uncompressed configuration.
5. The suture delivery device of claim 1, wherein the suture
catcher comprises a membrane that retains a suture inserted into or
through the membrane.
6. The suture delivery device of claim 1, wherein the suture
catcher comprises struts configured to close about a suture, and
wherein the first area of the deployed suture catcher comprises a
first area between the struts and the second area of the deployed
suture catcher comprises a second area between the struts.
7. The suture delivery device of claim 6, wherein the struts are
provided with teeth that engage the suture upon the strut closing
about the suture.
8. The suture delivery device of claim 6, wherein the suture
catcher further comprises a membrane, the membrane and the struts
being configured to position the membrane in the first and second
areas between the struts, the membrane retaining a suture inserted
into or through the membrane.
9. The suture delivery device of claim 1, wherein the suture
catcher comprises struts, each strut with an attached flexible
wing, wherein the first area of the deployed suture catcher
comprises a first area between a first strut and a second strut,
and the second area of the deployed suture catcher comprises a
second area between a third strut and a fourth strut, wherein when
the suture catcher is deployed the wings of the first and second
struts unfold to position themselves in the first area between the
struts and the wings of the third and fourth struts unfold to
position themselves in the second area between the struts, wherein
the wings in the first area are configured to retain a suture
between them and the wings in the second area are configured to
retain a suture between them, and wherein the first and second
struts are configured to close about a suture retained by the wings
of the first and second struts and the third and fourth struts are
configured to close about a suture retained by the wings of the
third and fourth struts.
10. The suture delivery device of claim 1, wherein the first and
second needle tracks are integrated into the elongated deployment
member and exit the elongated deployment member proximally from the
counterforce member.
11. The suture delivery device of claim 10, wherein the first and
second needle tracks are joined by a suture exit slot configured to
allow a suture loop to exit the device.
12. The suture delivery device of claim 1, wherein: the compression
member is configured to move axially along the elongated deployment
member in transitioning between the uncompressed and compressed
configurations, the first and second needle tracks each pass
through both the compression member and the elongated deployment
member, the first and second needle tracks comprise respective
first and second pairs of telescoping tubes, a first tube of each
telescoping pair anchored at the compression member and a second
tube of each telescoping pair anchored at the elongated deployment
member to allow for angular changes, motion of the compression
member along the elongated deployment member results in the
telescoping pairs of tubes varying an angle of the first needle
track with respect to the elongated deployment member and an angle
of the second needle track with respect to the elongated deployment
member, the varying of the angles between the first and second
needle tracks and the elongated deployment member resulting in
varying the first and second areas of the suture catcher.
13. The suture delivery device of claim 1, further comprising a
suture passer, the suture passer comprising: a needle tube
dimensioned to be accepted within the first or second needle track;
a shaft disposed within the needle tube, the shaft having a ramp on
a distal end, the ramp, shaft, and needle tube configured to retain
a suture when the ramp is at least partially covered by the needle
tube and to release a suture when the ramp is not covered by the
needle tube; and a trigger, the trigger causing, when moved in a
proximal direction, the ramp to be uncovered, wherein the first and
second needle tracks, needle tube, shaft, and trigger are
configured to uncover the ramp when the suture passer is inserted a
pre-determined distance into the first or the second needle track,
and wherein the pre-determined distance positions the suture for
capture by the suture catcher.
14. The suture delivery device of claim 1 wherein the first needle
track and the second needle track each have a constriction between
their proximal and distal ends, the constriction providing a point
about which a suture passer in the first or second needle track may
pivot and thereby vary the locations of the first and second areas
of the suture catcher when in the deployed configuration.
15. The suture delivery device of claim 1 further comprising: a
suture cassette provisioned with at least one suture; and a suture
cassette port intersecting the first and the second needle tracks,
wherein the suture cassette and the suture cassette port are
configured to position a first suture end within the first needle
track and a second suture end within the second needle track.
16. The suture delivery device of claim 1, further comprising: a
third needle track associated with the elongated deployment member
and disposed to direct a third suture end towards a third area of
the suture catcher when in the deployed configuration; and a fourth
needle track associated with the elongated deployment member and
disposed to direct a fourth suture end towards a fourth area of the
suture catcher when in the deployed configuration, wherein the
third area of the suture catcher when in the deployed configuration
and the fourth area of the suture catcher when in the deployed
configuration are situated on the suture catcher to allow their
placement on opposite sides of an incision.
17. The suture delivery device of claim 16, further comprising a
dial configured to allow access to either the first and second
needle tracks, or the third and fourth needle tracks.
18. The suture delivery device of claim 1, further comprising: a
first suture passer within the first needle track; a second suture
passer within the second needle track; and a deployment button,
wherein the deployment button is configured to advance the first
and second suture passers through the first and second needle
tracks, respectively.
19. A suture delivery device for suturing tissue comprising: an
elongated deployment member; a counterforce member disposed towards
a distal end of the elongated deployment member, wherein the
counterforce member is configured to transition between a retracted
configuration that facilitates the counterforce member entering an
incision and a deployed configuration that resists extracting the
counterforce member from an incision; a compression member disposed
towards a proximal end of the elongated deployment member with
respect to the counterforce member, wherein the compression member
is configured to resist entering an incision, and wherein the
compression member is positionable along the elongated deployment
member to transition between a compressed configuration and an
uncompressed configuration; a suture catcher disposed at the distal
end of the elongated deployment member, wherein the suture catcher
is configured to transition between a retracted configuration that
facilitates the suture catcher entering an incision and a deployed
configuration that facilitates catching a suture; a first needle
track extending through the compression member and oriented to
direct a needle advanced through the first needle track into
engagement with a first area of the suture catcher when in the
deployed configuration; and a second needle track extending through
the compression member and oriented to direct a needle advanced
through the second needle track into engagement with a second area
of the suture catcher when in the deployed configuration, wherein
the first area of the suture catcher when in the deployed
configuration and the second area of the suture catcher when in the
deployed configuration are situated on the suture catcher to allow
their placement on opposite sides of an incision.
20. A suture delivery device for suturing tissue comprising: an
elongated deployment member; a counterforce member disposed towards
a distal end of the elongated deployment member, wherein the
counterforce member is configured to transition between a retracted
configuration that facilitates the counterforce member entering an
incision and a deployed configuration that resists extracting the
counterforce member from an incision, and wherein the counterforce
member includes a suture catcher; a compression member disposed
towards a proximal end of the elongated deployment member with
respect to the counterforce member, wherein the compression member
is configured to resist entering an incision, and wherein the
compression member is positionable along the elongated deployment
member to transition between a compressed configuration and an
uncompressed configuration; a first needle track extending through
the compression member and oriented to direct a needle advanced
through the first needle track into engagement with a first area of
the suture catcher when in the deployed configuration; and a second
needle track extending through the compression member and oriented
to direct a needle advanced through the second needle track into
engagement with a second area of the suture catcher when in the
deployed configuration, wherein the first area of the suture
catcher when in the deployed configuration and the second area of
the suture catcher when in the deployed configuration are situated
on the suture catcher to allow their placement on opposite sides of
an incision.
Description
FIELD OF THE PRESENT DISCLOSURE
The present disclosure relates generally to techniques and devices
for the closing of small incisions in a patient's body. For
example, the present disclosure relates to systems, devices, and
methods for the closure of laparoscopic port sites, which is needed
following a variety of minimally invasive surgical procedures,
e.g., a cholecystectomy, an appendectomy, or a bariatric
surgery.
BACKGROUND
Laparoscopic surgery is a type of minimally invasive surgery. It is
a substitute for traditional "open" surgeries and provides the
benefits of minimizing post-operative pain, decreasing hospital
stays and periods of disability, and reducing costs for both
hospitals and patients.
Over 7.5 million laparoscopic surgeries are performed worldwide
each year in the areas of, e.g., cholecystectomy, appendectomy,
bariatric surgeries, gynecological surgeries, and urological
surgeries. However, because of the incidence rate of port-site
herniation for the laparoscopic surgeries, port-site closure is
preferred for fascial incisions greater than or equal to 10 mm.
Port-site closure can effectively reduce the rate of herniation,
reducing the need for hernia repair surgery, which has estimated
costs of between US$6,000-US$10,000 per procedure and three-week
recovery times. Approximately 70% of the laparoscopic procedures
performed have 10 mm or larger port-sites.
To ameliorate these problems, techniques for suturing the port site
have been developed. Despite the benefits associated with the use
of suture delivering devices, a number of challenges exist. Devices
for port-site closure can rotate, tilt, and slide downward
vertically in the wound track or incision during the insertion of a
suture needle. If the device rotates, the suture will be deployed
at less that the ideal 180 degree placement across the wound. If
the device slides vertically during the insertion, the tissue bite
of desired muscle/fascia layer is reduced for devices that use the
peritoneum as a reference point for needle entry into the
muscle/fascia layers. That is, if such a device is not engaged
against the peritoneum due to downward sliding, the needle entry
point into muscle/fascia layers will be lower than the intended
position and reduce tissue bite. It is also desirable to provide a
device configured to deploy the needles in a reproducible manner to
minimize the amount of skill required from the operator.
Accordingly, this disclosure is directed to systems and methods for
wound closure that provide these and other desired
characteristics.
SUMMARY
This disclosure includes a suture delivery device for suturing
tissue. In an embodiment, the delivery device includes an elongated
deployment member. Towards the distal end of the elongated
deployment member, a counterforce member is configured to
transition between a retracted configuration that facilitates the
counterforce member entering an incision and a deployed
configuration that resists extracting the counterforce member from
an incision. Towards the proximal end of the elongated deployment
member, a compression member is configured to resist entering an
incision. The compression member and the counterforce member
transition between a compressed configuration and an uncompressed
configuration. In the compressed configuration, tissue may be
sandwiched between the compression member and the counterforce
member to stabilize the device. A suture catcher disposed towards
the distal end of the elongated deployment member is configured to
transition between a retracted configuration that facilitates the
suture catcher entering an incision and a deployed configuration
that facilitates catching a suture. A first needle track is
associated with the elongated deployment member and is oriented
towards a first area of the suture catcher when in the deployed
configuration. A second needle track is also associated with the
elongated deployment member and is oriented towards a second area
of the suture catcher when in the deployed configuration. The first
area of the suture catcher when in the deployed configuration and
the second area of the suture catcher when in the deployed
configuration are situated on the suture catcher to allow their
placement on opposite sides of an incision. The first and second
needle tracks may pass through the elongated deployment member.
In an embodiment, the compression member is configured to resist
entering an incision, and is position-able along the elongated
deployment member to transition between a compressed configuration
and an uncompressed configuration.
In an embodiment, the compression member is configured to resist
entering an incision, and is position-able along the elongated
deployment member to transition between a compressed configuration
and an uncompressed configuration. This embodiment also includes a
counterforce member that is configured to transition between a
retracted configuration that facilitates the counterforce member
entering an incision and a deployed configuration that resists
extracting the counterforce member from an incision. In this
embodiment, the counterforce member also includes a suture
catcher.
BRIEF DESCRIPTION OF THE DRAWINGS
Further features and advantages will become apparent from the
following and more particular description of the preferred
embodiments of the disclosure, as illustrated in the accompanying
drawings, and in which like referenced characters generally refer
to the same parts or elements throughout the views, and in
which:
FIGS. 1A and 1B depict a side view of an embodiment of a suture
delivery device handle;
FIGS. 2A-2C depict perspective views of an embodiment of a suture
passer;
FIG. 3 depicts a perspective view of an embodiment of a suture
delivery device handle with suture passer inserted;
FIGS. 4A-4C depict an embodiment of a suture delivery device with a
suture escape slot;
FIGS. 5A and 5B depict cross-sections of an embodiment of a suture
delivery device with telescoping needle tracks;
FIGS. 6A-6C depict an embodiment of a suture catcher;
FIG. 7 depicts a cross-sectional perspective of a section of an
embodiment of a suture delivery device;
FIGS. 8A-8G depict stages in the use of an embodiment of a suture
delivery device handle and suture passer;
FIGS. 9A and 9B depict a side view of stages of retracting an
embodiment of a suture catcher;
FIGS. 10A and 10B depict an embodiment for automatically releasing
a suture;
FIG. 11 depicts an embodiment of a suture catcher in
cross-section;
FIGS. 12A and 12B depict embodiments of attaching membranes to
struts;
FIGS. 13A-13D depict embodiments of attaching membranes to
struts;
FIGS. 14A and 14B depict an embodiment for attaching a membrane to
a strut;
FIGS. 15A and 15B depict an embodiment for attaching a membrane to
a strut;
FIG. 16 depicts a perspective view of an embodiment for attaching a
membrane to a strut;
FIG. 17 depicts an embodiment for managing membrane sag;
FIGS. 18A and 18B depict an embodiment of a suture delivery device
handle;
FIGS. 19A and 19B depict an embodiment of a suture delivery device
handle;
FIGS. 20A-20C depict an embodiment of a suture catcher;
FIGS. 21A-21E depict embodiments of a multi-use suture catcher;
FIGS. 22A-22D depict embodiments of a suture passer tip;
FIGS. 23A and 23B depict an embodiment of a suture delivery
device;
FIGS. 24A-24E depict embodiments of a suture catcher;
FIGS. 25A and 25B depict an embodiment of a suture catcher;
FIG. 26 depicts an embodiment of a suture catcher; and
FIG. 27 depicts an embodiment of a suture catcher.
DETAILED DESCRIPTION
At the outset, it is to be understood that this disclosure is not
limited to particularly exemplified materials, architectures,
routines, methods or structures as such may vary. Thus, although a
number of such options, similar or equivalent to those described
herein, can be used in the practice or embodiments of this
disclosure, the preferred materials and methods are described
herein.
It is also to be understood that the terminology used herein is for
the purpose of describing particular embodiments of this disclosure
only and is not intended to be limiting.
The detailed description set forth below in connection with the
appended drawings is intended as a description of exemplary
embodiments of the present disclosure and is not intended to
represent the only exemplary embodiments in which the present
disclosure can be practiced. The term "exemplary" used throughout
this description means "serving as an example, instance, or
illustration," and should not necessarily be construed as preferred
or advantageous over other exemplary embodiments. The detailed
description includes specific details for the purpose of providing
a thorough understanding of the exemplary embodiments of the
specification. It will be apparent to those skilled in the art that
the exemplary embodiments of the specification may be practiced
without these specific details. In some instances, well known
structures and devices are shown in block diagram form in order to
avoid obscuring the novelty of the exemplary embodiments presented
herein.
For purposes of convenience and clarity only, directional terms,
such as top, bottom, left, right, up, down, over, above, below,
beneath, rear, back, and front, may be used with respect to the
accompanying drawings. These and similar directional terms should
not be construed to limit the scope of the disclosure in any
manner.
Unless defined otherwise, all technical and scientific terms used
herein have the same meaning as commonly understood by one having
ordinary skill in the art to which the disclosure pertains. For
example, the term "suturing" includes drawing two surfaces or edges
together with a flexible material to close a puncture, opening, or
other wound, wherein the suture is a material that may be synthetic
or natural, such as a polymer, gut, metallic wire or other suitable
equivalents.
As used in this specification and the appended claims, the singular
forms "a, "an," and "the" include plural referents unless the
content clearly dictates otherwise.
Embodiments within describe a suture delivery device that may be
inserted into the same opening used to perform a surgical
procedure, such as laparoscopic surgery. The suture delivery device
decreases the potential for tilting, rotating, or sliding relative
to the opening by compressing the surrounding tissue, thereby
stabilizing the device within the opening. Thus stabilized, the
suture delivery device is able to improve tissue bite by reliably
directing a suture to a pre-determined tissue area or layer. The
suture delivery device may be used to orient one or more suture
passers, which pass through the body of the delivery device to
pierce through the port-site tissue and release the suture after
the piercing. The suture delivery device captures the sutures and,
upon withdrawing the delivery device, the suture ends are drawn
back through the opening so that the suture may be secured and the
opening closed. Embodiments are easy to use, which is important for
a tissue closure device, which may be a last step in long, tiring
surgical procedure.
A suture delivery device (or "wound closure device," or "trocar
wound closure device" (TWC)) generally has two parts: a handle 100
(FIGS. 1A, 1B) and a suture passer (FIGS. 2A-2C). FIGS. 1A and 1B
depict two configurations of an embodiment of a suture delivery
device handle 100. The configuration in FIG. 1A is used when the
device is inserted into an opening. In FIG. 1A, handle 100 is in an
uncompressed configuration. FIG. 1A depicts handle 100 with a shaft
105, a catcher 110 (including catcher elements 112, 114), a slider
115, needle tracks 150, 155, and a suture exit slit 160. Shaft 105
is an elongated deployment member equipped with a ridged track 120.
Slider 115 is a compression member that may be moved along shaft
105 toward a distal end 135 and fixed in position by engaging track
120. Anti-rotation bumps, not shown, along with track 120 prevent
slider 115 from rotating relative to needle tracks 150, 155 (FIG.
1B). Slider button 125 may be used to engage or disengage track
120. Catcher 110, shown closed, is a counterforce member when
deployed and may include teeth 140, which may close about and grasp
a suture. Control button 130, shown depressed, moves a control rod
145 (FIG. 1B), which opens (or deploys) or closes catcher 110 by
moving struts 165, 170. With catcher 110 closed, distal end 135,
catcher 110, and shaft 105 may be inserted into a surgical opening
until catcher 110 is through the opening, at which point catcher
110 may be deployed as shown in FIG. 1B.
In FIG. 1B, handle 100 is in a compressed configuration, with
control button 130 shown released, control rod 145 visible, catcher
110 deployed, and slider 115 moved distally. To deploy catcher 110,
control button 130 is released, to move control rod 145 proximally
(i.e., toward control button 130, or "up" in this view), causing
struts 165, 170 to deploy catcher 110. To move slider 115 either
proximally or distally, slider button 125 is used to disengage
slider 115 from track 120 and then slider 115 may then be moved.
Optionally, slider 115 may ratchet distally along shaft 105, with
slider button 125 used to disengage slider 115 from track 120 and
move slider 115 proximally (see FIG. 7).
The configuration in FIG. 1B may compress tissue between slider 115
and catcher 110. For example, the fascia, muscle and peritoneum
layer of an abdominal wall may be compressed between slider 115 and
catcher 110, with the peritoneum nearest to catcher 110. As shown
deployed, catcher 110 would resist being pulled through the opening
in the abdominal wall. Thus, in this embodiment, catcher 110 is a
counterforce member. In other embodiments, a counterforce may be
applied by elements that lack suture catching capabilities.
Similarly, in other embodiments, suture-catching capability may be
supplied by elements that lack counterforce capability.
In this configuration, with tissue compressed between slider 115
and catcher 110, handle 100 is stabilized relative to the
compressed tissue, reducing the potential for rotation, sliding, or
tilting. Furthermore, with handle 100 stabilized, needle tracks
150, 155 are also stabilized relative to the surrounding tissue,
which is the tissue to be sutured. This provides for the optimal
placement of sutures and for deploying sutures in a reproducible
manner, both of which work to ensure proper tissue bite and
minimize the amount of skill required from an operator.
FIGS. 2A-2C depict an embodiment of a suture passer 200. Suture
passer 200 is used to grasp a suture end and pass the suture
through a needle track, e.g., needle track 150, to position the
suture so it may be caught by catcher 110. Suture passer 200
includes a hook 205 at a distal end, a needle tube 210, a shaft
215, a trigger 220, and a needle button 225. Hook 205 is at the
distal end of shaft 215. Needle tube 210 has a point at the distal
end and may move relative to shaft 215 to cover or uncover hook
205. Hook 205 is configured to accept a suture 230 (see FIG. 2B)
and, when covered by needle tube 210, retain the suture (see FIG.
2C). Hook 205 may have a blunt tip--a point not being necessary
while loading the suture. Hook 205 may also have a ramp 235 that
allows a suture to slide off when hook 205 is uncovered. In FIG.
2A, needle button 225 is shown extended (not pressed) and hook 205
is shown uncovered. Needle button 225, when pressed, may extend
needle tube 210 over hook 205 to retain a suture. Trigger 220, when
pressed, may result in needle tube uncovering hook 205 to release a
suture. Needle tube 210, shaft 215, hook 205, and trigger 220 are
configured to fit within needle tracks 150, 155 and to deliver and
release a suture in a desired location relative to a deployed
catcher 110.
FIGS. 2B and 2C generally depict the loading of suture passer 200.
Suture passer 200 has two states that are controlled by needle
button 225 and trigger 220. In the initial "off" state shaft 215
and hook 205 protrude from the needle tube 210. Hook 205 is used to
receive the suture in this configuration. That is, suture 230 may
be positioned to be grabbed by hook 205. To transition to an "on"
state, a user presses needle button 225, which causes needle tube
210 to extend to cover suture 230 and hook 205. Thus, shaft 215,
hook 205, and needle tube 210 cooperate to retain or grasp suture
230. To return to the "off" state, trigger 220 may be activated by
pressing it in the proximal direction. Pressing trigger 220 may
thereby release suture 230.
FIG. 3 depicts a suture delivery device 300. In FIG. 3 suture
passer 200 inserted into needle track 150 of handle 100. Handle 100
is in a compressed configuration with catcher 100 deployed and
slider 115 moved distally. Needle button 225 is shown depressed,
with needle tube 210 covering hook 205 (not shown). The distal tip
of needle tube 210 is near a membrane 302. Membrane 302 extends
between catcher elements 114 and 314. Membrane 305 extends between
catcher elements 112 and 312.
As shown in FIG. 3, needle track 150 has oriented suture passer 200
to point to an area between catcher elements 114 and 314 of
deployed catcher 110. In this embodiment, catcher 110 has been
provisioned with membrane 302 in that area. Membrane 302 is added
to improve the ability of catcher 110 to catch a suture. If suture
passer 200 is inserted further into needle track 150 the sharp
point of needle tube 210 would pierce membrane 302, carrying a
suture (not shown) with it. Further insertion would cause trigger
220 to touch the opening of needle track 150. Still further
insertion would cause trigger 220 to actuate and cause needle tube
210 to retract, exposing hook 205 and releasing the suture (not
shown). At that point, suture passer 200 could be withdrawn from
needle track 150. Withdrawing suture passer 200 from the needle
track would also withdraw it from membrane 302. But the suture,
having been released from hook 205, would be retained within
membrane 302. Then, if catcher 110 is then retracted, membrane 302
is also retracted, bringing the suture with it to be grasped by
catcher elements 114, 314. This is described further with respect
to FIGS. 9A and 9B.
FIGS. 4A-4C depict an embodiment of a handle 100 providing
automatic suture release. When two ends of a single suture are
delivered into a surgical opening and retained at the distal end of
the suture deliver device, the portion of the suture near the
proximal end forms a loop. The loop could become entangled with the
device during device retrieval. Existing closure devices allow for
the operator to manually disengage the suture from the device. The
embodiment of FIGS. 4A-4C uses an internal suture escape slot 400
that facilitates the automatic release of suture 415. Suture escape
slot 400 connects needle tracks 150, 155 throughout their length,
providing a slot for a suture 415 to pass through handle 100 and
out suture exit slot 160. In FIG. 4A, suture passer 200 is inserted
in needle track 155 and extends from shaft 105 exposing needle tube
210. Needle tube 210 is shown after piercing membrane 305. A suture
tip 410 of suture 415 is shown also passing through membrane 305,
having been carried through by the tip of suture passer 200.
Control button 130 is shown extended. Thus, needle tube 210 is not
covering hook 205 and suture end 410 is released from suture passer
200 (though the needle tip is obscured in FIG. 4A by membrane 305).
Needle track 150 shows suture 415 after suture end 405 has been
passed through membrane 302, released, and suture passer 200
withdrawn. As shown in FIG. 4A, both suture ends 405, 410 are
retained by membranes 302, 305. From suture end 405, suture 415
passes through and out of needle track 150, loops over handle 100,
and, accompanied by suture passer 200, enters needle track 155. In
FIGS. 4A-4C, slider 115 is not shown to more clearly explain the
internal suture escape path.
In FIG. 4B, suture passer 200 has been withdrawn from needle track
155 and catcher 110 has been retracted, grasping suture ends 405,
410. Handle 100 may be withdrawn from a surgical opening in this
configuration, pulling suture ends 405, and 410 with it. Suture 415
makes a loop between a needle track exit 152 and catcher 110.
Suture 415 also makes a loop between a needle track exit 157 and
catcher 110. These loops represent portions of suture 415 that have
passed through the tissue to be sutured. Thus, when handle 100 is
removed from the surgical opening, pulling suture ends 410, 415
with it, the sections of suture 415 looped through the tissue will
pull the remainder of suture 415 down through suture escape slot
400 (as shown, dotted). In FIG. 4C, suture 415 has passed
completely through suture escape slot 400 and out suture exit slot
160.
Thus, with reference to FIGS. 1-4, embodiments of handle 100 of
suture delivery device 300 may include needle track elements, e.g.,
needle tracks 150, 155, and a suture retention element, e.g.,
catcher 110. The needle track elements may extend from the proximal
end towards distal end of handle 100 and may include an auto suture
release mechanism, e.g., suture escape slot 400. The suture
retention element may be disposed at or near the distal end of
handle 100. The suture delivery device may also have a compressive
element, e.g., slider 115.
The needle track elements may provide defined trajectories for
needles (e.g., suture passer 200) inserted through the handle
(e.g., handle 100), beginning near the proximal end and exiting
near the distal end. For example, with the handle inserted into a
surgical opening, a needle may enter the proximal end of a needle
track element (e.g., needle track 150) above the skin, travel
through the needle track in the device, and exit at the distal end
to penetrate through tissues layers (such as fascia, muscle, and
peritoneum) at defined position and angle relative to the handle.
The needle trajectory may be completely enclosed by the handle
between entry and exit. The needle track element may be coupled
with an auto suture release mechanism (described with reference to
FIGS. 4A-4C) whereby the suture loop (or main section of the
suture, excluding the suture ends) is not retained at the device's
distal end and may slide out, without user intervention, from the
needle track as the handle is withdrawn from the surgical
opening.
The suture retention element (e.g., catcher 110) may comprise a
frame (e.g., catcher elements 112, 114, 312, 314) and suture
capture surface(s) (e.g., membranes 302, 305) or a frame only. The
suture retention element may be provided with features to improve
its grip on the suture (e.g., teeth 140). The suture retention
element frame may have multiple struts and may have various
geometries (e.g., flat, lantern, molly, umbrella, etc.). The suture
retention element frame may define a target area and may provide a
counterforce to the compressive force of the compressive element,
sandwiching the tissue in between. This counterforce may be
against, for example, the peritoneum. The suture retention element
may also provide support to an optional suture capture surface
during needle insertion. The suture retention element may be
inserted through the tissue opening in a low profile or retracted
state and deployed to its expanded state after passing through
tissue layers to the intended position, which may be, for example,
inside the peritoneal cavity. The suture capture surface may be
coupled to the struts of the frame, and may be in a folded
configuration during device insertion as well as during device
withdrawal.
A needle (e.g., suture passer 200) carrying a suture may be
introduced into a needle track element (e.g., needle track 150),
guided to penetrate through tissue layers (e.g., past the
peritoneum), and inserted into the catcher (e.g., positioned
between catcher elements 112, 312, or inserted into membrane 305).
The design of the distal tip of the needle may allow the suture to
be disengaged from the needle (e.g., hook 205 may have a ramp 235
that allows suture 230 to slide off, rather than a true "hook"). In
some embodiments, the needle may be triggered to release the suture
from its tip when the needle is inserted to an intended
position.
In embodiments, the needle tip design (e.g., ramp 235) may allow
the suture to disengage from the needle. In embodiments with a
capture surface (e.g., membranes 302, 305), the surface itself may
have a property or a design that enhances the capture and retention
of suture by the surface, which assists disengaging the suture from
the needle.
The device may be withdrawn from the surgical opening (e.g., a
trocar wound) while retaining the captured suture ends at the
distal end of device (e.g., in the catcher).
In an embodiment, the membrane is essentially enclosed by the
catcher frame during the insertion and withdrawal of the catcher
through tissue layers. In embodiments, the suture ends may be
captured in the membrane as well as held between struts of the
closed catcher frame. In an embodiment in which the suture
retention element includes a frame, the suture ends may be retained
by mechanical clamping between struts of the closed frame during
device retrieval.
The suture delivery device may also have a compressive element,
e.g., slider 115, that is movable along the device shaft to adapt
for varying anatomy. The compressive element may be placed in a
position that sandwiches tissue against a counterforce member
(e.g., catcher 110). For example, the tissue may be the layers of
the abdominal wall, the counterforce member may be positioned in
the abdominal cavity against the peritoneum, and the compressive
element may be against the surface of the skin. The compressive
element thereby stabilizes the tissue while adapting to varying
anatomy. In some embodiments, the compressive element may be linked
to a counterforce member deployment mechanism so that movement of
the compressive element causes the counterforce member to deploy
and retract.
FIGS. 5A and 5B show cross-sections of an embodiment of handle 100
with telescoping needle tracks 153, 158. In FIG. 5A, handle 100 is
in an uncompressed configuration with slider 115 extended
proximally, away from catcher 110. For simplicity, and because
telescoping needle tracks 153, 158 are similar, only telescoping
needle track 153 will be described. Telescoping needle track 153
includes a pair of tubes 505, 510 configured to telescope, tube 510
within tube 505. In an embodiment (not shown), tube 505 moves
within tube 510, so that a suture passer would avoid hitting the
end of tube 510 when inserted. In FIGS. 5A and 5B, tube 505 is
anchored at the non-telescoping end to slider 115. Tube 510 is
anchored at the non-telescoping end to shaft 105. The anchor
attachments allow angular motion between the tube and anchor point.
In FIG. 5B, handle 100 is in a compressed configuration with slider
115 moved distally, toward catcher 110. With that motion,
telescoping needle tracks 153, 158 have shortened in length and
changed the angle at which they exit handle 100. Still, telescoping
needle tracks 153, 158 are oriented to direct a suture passer
towards catcher 110. In the movement of slider 115 from the
uncompressed to compressed configuration, telescoping needle track
153 has swept out a volume within shaft 105 bounded by an upper
limit 520, a lower limit 525, and needle track exit 152. In this
embodiment, handle 100, shaft 105, and slider 115 are configured to
permit this motion of telescoping needle tracks 153, 158.
In a method of using an embodiment, handle 100 is initially in the
uncompressed and retracted configuration. In a first step, handle
100 is inserted into the trocar wound. In a next step, control
button 130 is pressed to open the catcher 110. In a next step,
handle 100 is pulled up against the tissue until the catcher 110 is
in contact with the peritoneum. In a next step, slider 115 is
pushed down to sandwich the abdomen wall against the catcher 110.
The handle is then stabilized within the tissue to be sutured. In a
next step, one end of suture 230 is loaded onto hook 205 and needle
button 225 is pressed. In a next step, suture passer 200 is
inserted into a needle track and trigger 220 is activated,
releasing suture 230. In a next step, suture passer 200 is
withdrawn from handle 100. In a next step, a second end of suture
230 (or the end of a different suture) is loaded onto hook 205 and
the previous two suture-passing steps repeated in a different
needle track. Handle 100 may now be withdrawn, taking with it the
suture ends according to the following steps. In a next step,
control button 130 is pressed to capture the suture ends with
catcher 110 (the suture ends may also have been retained by
optional membranes 302, 305). In a next step, handle 100 is
withdrawn from the surgical opening, bringing with it the suture
ends. The suture ends are then removed from handle 100 and
knotted.
FIGS. 6A-6C depict an embodiment of a suture catcher 110 in
retracted, partially deployed, and fully deployed configurations,
respectively. In FIG. 6A, suture catcher 110 has hinge joints 705,
710, 715, struts 165, 170 and catcher elements 112, 114. Joints
705, 710, 715 may be a mechanical, or a living hinge, or a
combination. In FIG. 6B, catcher 110 has been expanded to a
partially deployed status by using control rod 145 to urge struts
165, 170 against catcher elements 112, 114. Catcher elements 312,
314 have been similarly deployed. In FIG. 6C, catcher 110 has been
fully deployed using control rod 145. FIG. 6C also shows optional
membranes 302, 305 attached to catcher elements 112, 114. Control
button 130 (FIGS. 1 and 3) may be connected to control rod 145 and
used to activate control rod 145.
FIG. 7 depicts in cross-section a section of an embodiment of
handle 100. In the embodiment of FIG. 7, slider 115 may move easily
toward the distal direction, but not toward the proximal direction,
using a ratchet 805 and rack 810. Thus, slider 115 may easily move
toward a compressed configuration, but not an uncompressed
configuration. In the embodiment, pushing slider button 125
releases ratchet 805, allowing slider 115 to move proximally. Rack
810 may include a lower limit (not shown) that prevents the slider
from moving too far in the compressive direction. In an embodiment,
a friction pad (not shown) is used between slider 115 and shaft
105. The shape of the friction pad is designed to modulate pushing
friction in two directions.
FIGS. 8A-8G depict an embodiment in the various stages of deploying
a suture. FIG. 8A is a perspective view of a loaded suture passer
200 inserted into needle track 150. In FIG. 8A, catcher 110 is in
the deployed configuration. Needle tube 210, grasping suture end
405, has exited needle track 150, but has not yet penetrated
membrane 302. In FIG. 8B, suture passer 200 has been further
inserted into needle track 150 so that needle tube 210 has
penetrated membrane 302 (not shown), taking suture end 405 through
membrane 302 as well. In FIG. 8B, needle tube 210 is shown piercing
three layers of tissue 902, 904, 906. Thus, eventually, the bite of
suture 230 will include those layers. In FIG. 8C, suture passer 200
has been inserted still further into needle track 150, causing
trigger 220 to be depressed, which, as described with reference to
FIGS. 2A-2C, resets needle tube 210 to "off" and releases suture
230 from suture passer 200. FIG. 8D depicts a close-up of the
device from FIG. 8C. In FIG. 8D, needle tube 210 and suture end 405
have penetrated membrane 302. Suture end 405 is seen to be free of
hook 205 and needle tube 210. In FIG. 8E, suture passer 200 has
been withdrawn from needle track 150. Suture end 405 has been
retained--held by the retentive squeezing properties of membrane
302. FIG. 8F depicts the process being repeated with suture end
410, needle track 155, and membrane 305 (not shown). FIG. 8F also
depicts the bite of the suture with suture ends 405, 410 each
passing through tissue layers 902, 904, 906. And FIG. 8G depicts
handle 100 after suture passer 200 has deployed suture ends 405,
410 into membranes 302, 305, respectively, and been withdrawn.
FIGS. 9A and 9B depict a handle 100 at different stages of
capturing the suture ends. After suture ends 405, 410 are deployed
onto membranes 302, 305 (as in FIG. 8G), control button 130 is
pressed, moving control rod 145 distally to close catcher 110. FIG.
9A depicts handle 100 approximately mid-way through the process of
capturing suture ends. As control button 130 is depressed,
membranes 302, 305 fold between catcher elements 114, 314 (FIG. 3)
and 112, 312 (FIG. 3), respectively, bringing suture ends 405, 410
with them. FIG. 9B depicts catcher 110 in the retracted
configuration. Control button 130 has been fully depressed. In this
configuration catcher 110 no longer provides a counterforce to the
compressive forces of slider 115, which is still in the compressive
position. That is, catcher 110 no longer presents a flat surface to
tissue layers 902, 904, 906 and may be easily withdrawn. In the
fully retracted position, elements 114, 314 and 112, 312 clamp
respective suture ends 405, 410. Optional teeth 140, which may also
be between catcher elements 112, 312 and 114, 314 (see FIGS. 6C,
8D) improve the hold on suture ends 405, 410.
FIGS. 10A and 10B depict an embodiment of a handle 100
automatically releasing the suture after catcher 110 has been fully
retracted. In FIG. 10A, suture 230 has been deployed onto layers
902, 904, 906 of, for example, the abdomen wall with suture ends
405, 410 captured by catcher 110 on handle 100. Handle 100 has been
pulled from surgical opening 1100, carrying with it suture ends
405, 410 and pulling more of suture 230 into surgical opening 1100
and through tissue layers 902, 904, 906. This has caused the loop
of suture 230 to enter suture escape slot 400 (see FIGS. 4A-C). In
FIG. 10B, continued pulling on handle 110 has caused the remainder
of suture 230 to pass through suture escape slot 400 and out suture
exit slot 160.
A method of using an embodiment to close a wound begins with the
suture delivery device handle in the uncompressed and retracted
configuration and the suture passer separated from the handle. In
step 1, one hand removes a trocar from a wound. In step 2, the
other hand inserts the handle into the trocar wound until the
catcher is completely visible in a laparoscope image. In step 3,
one finger presses the control button to open the catcher under
visual guidance using the laparoscope image. In step 4, one hand
holds the handle and the other hand pushes the slider toward the
patient until the tissue to be sutured is firmly sandwiched between
the slider and the catcher. The laparoscope image may be used to
show whether the catcher is in contact with the peritoneum wall. In
step 5, one hand holds the suture passer body and the other hand
puts one end of suture into the hook of the suture passer. The
finger then presses the needle button to load the suture passer. In
step 6, one hand holds the handle and the other hand inserts the
suture passer through the needle track until the trigger is
actuated, releasing (or deploying) the suture on the catcher, again
under the visual guidance of the laparoscope image. In step 7,
steps 5 and 6 are repeated with the other end of the suture and the
other needle track. In step 8, one finger presses the control
button to capture the suture ends under visual guidance. In step 9,
one hand pulls the handle from the wound and harvests from it the
two suture ends.
FIG. 11 depicts an embodiment of struts from a suture catcher
structure in a plan view and in cross-sections as part of an open
and a closed suture catcher structure. Suture catcher 1105 may
contain a number of struts 1110. Each strut 1110 may have a
proximal connection part 1115 to a proximal joint 1117 (an upper
hinge), an upper strut 1120, a middle hinge 1125, a lower strut
1130, a distal (or lower) hinge 1135, and a distal connection part
1140 to distal hinge 1135. The hinges may be living hinges,
mechanical hinges, or metal wire/plate spring hinges. The struts
may be made of metal (i.e. stainless steel), plastic (i.e.
polypropylene, polycarbonate, polyurethane, nylon, or polyethylene)
or any other suitable material. Multiple struts may be linked at
the proximal joint as well as at the distal joint to form a
catcher. A control rod 1145 may be coupled to the distal connection
part 1140 of the catcher and extended to the proximal end of suture
delivery device. In one embodiment, motion of control rod 1145
drives the up and down movement of distal connection part 1140
resulting in the opening (distal joint up, or "deploying") or the
closing (distal joint down, or "retracting") of the suture catcher.
In an alternate embodiment, the catcher deployment mechanism may be
driven by controlling proximal connection part 1115. In
embodiments, when in the deployed configuration catcher 1105 serves
as a counterforce member to tissue-compressing forces.
The lengths of the lower and upper struts may be selected based on
the desired size of the target area of catcher 1105, or based on
the desired angle formed between the upper and lower struts, or
both. The shape of the struts may be rectangular or trapezoid. An
advantage of a trapezoidal shape over a rectangular shape is that a
trapezoidal shape provides additional membrane packing space. The
outer surface of the struts (the surface visible in the retracted
configuration) has many possible variations including flat, flat
with curved edges, or curved. Designs with curved surfaces may
result in a suture delivery device with a more atraumatic outer
profile, since there would be fewer sharp edges. That is, in the
various embodiments, strut components (including protruding and
matching features) may be flat or may be curved to create a more
rounded exterior profile, see, e.g., FIG. 13C.
FIGS. 12A and 12B show embodiments of attaching a membrane 1200 to
a strut 1205. Membrane 1200 may be made of materials such as
polyurethane, PVC, polypropylene, or other pliable material that
would not resist being punctured or folded too greatly. To retain a
suture more reliably between struts during device withdrawal, the
catcher should close so that adjacent struts (or features for
securing a suture, such as teeth) can engage in the designed
manner. Proper closure of the catcher is much more likely if the
membrane folds and packs into a profile that does not interfere
with catcher frame closure. But catcher membranes may not naturally
fold or pack in any particular direction or configuration. In
addition, the space where the membrane may be packed is the space
enclosed by the struts when they are contracted, and that space is
limited. Furthermore, membranes with varying thickness and
stiffness have different folding behaviors. The membrane attachment
position relative to the strut has been found to impact its folding
behavior. Thus, in embodiments, the struts or frame of the catcher
may be designed to guide the membrane to fold in a desired manner,
e.g., radially inward toward control rod 1245 (FIG. 12B).
The membrane may be coupled to the frame struts by various methods
(e.g., adhesive, mechanical attachment, etc.). The membrane
attachment position may be fully extended to the edge of the strut
or may be attached in recessed position from the strut's lateral
edges. To facilitate full enclosure of membrane by the strut upon
catcher closure, membrane 1200 may be attached in recessed position
1210 from the lateral edges as shown in FIGS. 12A and 12B. Membrane
1200 typically has a minimum curvature and radius. Thus, attaching
membrane 1200 recessed from the edge of strut 1205 allows for
membrane 1200 to fold within the space defined by the struts, as
shown by fold 1215. This helps prevent membrane 1200 from
clustering between struts 1205 and reducing their ability to clamp
together and secure a suture.
FIGS. 13A-13D depict further embodiments for attaching a membrane
to a strut. In FIG. 13A, strut 1300 has a two-piece construction,
comprising an outer (or top) strut component 1305 and an inner (or
bottom) strut component 1310 that combine to sandwich membrane
1315. The outer strut component may be wider than the inner strut
component and a membrane attachment edge 1320 may be recessed from
the edges of the outer component 1305. The difference between outer
and inner strut component widths provides membrane attachment
support by sandwiching the membrane and facilitates membrane
folding by allowing membrane attachment edge 1320 to be recessed
from the edge of strut 1305. In FIG. 13B, a membrane guiding
feature 1325 may be used between strut 1305 and membrane 1315 to
help push the membrane inward. Guiding feature 1325 may be a part
of strut 1305, or membrane 1315, or a separate add-on component.
Guiding feature 1325 may be, for example, a metal rod. Guiding
feature 1325 protrude from the surface of the strut to increase or
initiate the folding of membrane 1315. Thus, instead of taking a
path more in parallel with strut 1305, membrane 1315 bends
immediately inwards to help achieve the intended membrane folding.
Protruding features of various shapes and sizes may be used to
create different membrane bending patterns as intended.
In FIG. 13C, outer strut component 1330 may have edges that curve
inward slightly to help facilitate membrane 1315 folding inward and
away from the outer strut edges as the catcher closes. FIG. 13D
depicts an embodiment of a catcher with a 2-piece strut design in a
closed configuration. Closed catcher 1340 also has an outer strut
component 1345 with an angled edge 1350 that increases the contact
surface between outer strut components 1345.
Generally, the membrane may be coupled to the catcher struts or
frame using various methods, such as adhesive, mechanical
attachment, fusing, injection molding, or any other suitable
means.
FIGS. 14A and 14B depict an embodiment for attaching a membrane
mechanically. In the embodiment, strut 1400 may have a two-piece
construction with an outer/top strut component 1405 and an
inner/bottom strut component 1410 that sandwich membrane 1415.
Membrane 1415 is preferably pliable and may be secured by
mechanical means, such as clamping or clasping. In this embodiment,
outer strut component 1405 and inner strut component 1410 have
interlocking features 1420 that assemble together to secure
membrane 1415. Interlocking features 1420 include a protruding
feature and a corresponding hole, which cooperate to fix membrane
1415 between struts 1405, 1410. Membrane 1415 elongates and
conforms around the protruding feature 1420. Positions 1430
indicate a possible pattern of features 1420. Alternately, membrane
1415 may have holes punched that correspond to features 1420, so
that membrane 1415 does not elongate to conform to features
1420.
FIGS. 15A and 15B depict an embodiment for attaching a membrane
mechanically. In FIG. 15A, membrane 1505 has holes that allow the
passing of protruding feature 1520. Alternatively, the protruding
feature may be designed to puncture through membrane 1505 during
the strut component interlocking process. A strut may contain
multiple protruding and matching features to form a desired
securing pattern.
Membrane attachment to the strut may be provided solely by the
mechanical force produced by the interlocking components.
Alternatively, adhesive may also be used to provide additional
membrane attachment force. In embodiments where the protruding
features are plastic and pass through holes in the membrane, the
protruding feature can be melted or welded to the other strut
component to provide an interlocking force. Additionally, the
membrane may also be heat fused to one or both of the strut
components.
Metal has an advantage over plastic in resisting creep and it
functions more effectively as a tension holding element. In an
alternate to the embodiment of FIG. 15A, membrane 1505 may stretch
over protruding feature 1520 while strut components with matching
feature in the form of "metal clip" are applied to sandwich
membrane 1505 to protruding feature 1520. The metal clip part may
be created by stamping or by any other appropriate method.
FIG. 15B depicts an addition to the embodiment of FIG. 15A. The
matching feature has the form of a thin metal part--a slide-lock
1525 with a slot 1530. Slot 1530 is sized to slide onto the neck of
protruding feature 1520. In this variation, the membrane has
punched out holes to admit the protruding features. Slide-lock 1525
may be stamped or laser cut or made by any other appropriate
method.
FIG. 16 depicts an embodiment for attaching a membrane
mechanically--by threading it through a strut. Small slits 1605 may
be created in a suture catcher strut 1610 and a membrane 1615 may
be threaded through these openings. The size, length, and geometry
of the openings may be optimized to control the attachment of
membrane 1615 to strut 1610. Membrane 1615 may be inserted through
a first slit 1605 from the interior side of strut 1610, traverse
the exterior side of strut 1610, and then be inserted through the
second slit 1605 to re-emerge on the interior side of strut 1610.
Additionally, adhesive or other methods may be used as adjunct
methods to increase the membrane-strut fixation force. Slits 1605
also serve the purpose of guiding or controlling the angle at which
membrane 1615 exits strut 1610. Slits 1605, since they are
positioned away from the lateral edges, result in membrane 1615
emerging on the interior of the strut recessed some distance from
the lateral edge. Membrane 1615 is therefore less likely to
interfere with strut closure as it has room to turn radially inward
and is already guided in that direction by the slits 1605.
In an alternate embodiment, slits 1605 may extend to one end of
strut 1605, creating openings for membrane 1615 to be slid into and
be retained by strut 1610 (akin to a paper clip). The opened edge
may be on the outer radial edge or on the inner edge in proximity
to the device shaft.
A membrane stretched between two struts has a tendency to sag along
the unsupported edges. In embodiments, membranes may sag,
particularly where they extend radially beyond a direct line
between two struts ends. In such sections the membrane does not
have sufficient support from the struts, and may not be stiff
enough itself to resist bending away when contacted by a needle or
suture passer. Such bending may reduce the effective target zone
for suture capture, since the needle may slide past the bending
membrane instead of penetrating it. Embodiments are directed to
managing the extent the membrane may sag or bend, many by improving
membrane tautness.
FIG. 17 depicts an embodiment of a catcher for managing the extent
the membrane may sag or bend. In FIG. 17, membranes 1705 have
straight-line edges 1710 that follow a line between the external
radial edges of two adjacent, opened struts 1715. Membranes 1705
may be more effective in capturing sutures than shapes where
membrane material extends beyond the line between strut ends (e.g.,
membranes with extended arc shaped outer edges). Straight-line
shaped membranes 1705 eliminate membrane areas that are not
well-supported by struts 1715 and thereby reduce the likelihood of
membrane 1705 bending upon needle contact. Thus, membranes 1705
maximize the effective suture capture area.
In an alternate embodiment, the membrane may be any shape, or
non-existent, between struts where suture capture is not intended,
i.e., where needle tracks are not directed.
In embodiments, the edge of membrane 1705 may be reinforced with a
tension element 1720 that improve membrane tautness. In one
embodiment, tension element 1720 may be a string or other fiber
coupled to the edge of the membrane with its ends attached to the
catcher struts, much like the string around the periphery of a
kite. For example, tension element 1720 may be a Kevlar fiber fused
at the edge of the membrane. The fiber may be stretched to create
tension in the fiber section between the strut ends and thereby
provide support to the outer edge of the membrane. A mechanism for
tensioning the fiber may be the deployment of the catcher struts.
An alternate or additional mechanism for tensioning the fiber may
be to cause the struts to extend radially outward after the catcher
struts have been deployed.
The fiber may be coupled to the membrane edge by different methods.
One method is to glue the fiber to the edge of the membrane.
Another method is to fold the membrane edge to create a pocket to
contain the fiber. Yet another method is to fuse membrane layers
together with the fiber embedded between the layers.
The tension element may be more pliable than the membrane so that
the tension element does not adversely impact membrane packing. In
embodiments, the tension element itself may have a default bend
that assists the folding of the membrane. The cross-section of a
tension element may be of any desired shape.
FIGS. 18A and 18B depict an embodiment of a suture delivery device
handle 1800. In embodiments, suture ends 1805, 1810 may be loaded
onto handle 1800 before handle 1800 is inserted into inserting into
the surgical opening. In FIG. 18A, suture ends 1805, 1810 have been
loaded onto handle 1800 at the distal openings 152, 157 of needle
tracks 150, 155. FIG. 18B depicts a friction method of loading a
suture. In FIG. 18B, slots 1815, 1820 are configured to retain
suture ends 1805, 1810, by, for example, a press-fit or other
wedging action. In an alternate embodiment, flexible retaining
flaps 1825, 1830 are added to further retain suture ends 1805,
1810. Flaps 1825, 1830 may be, for example, rubber or metal
depending on the retention force desired. Furthermore, handle 1800
may have suture ends 1805, 1810 loaded during the factory assembly
process.
FIGS. 19A and 19B depict an embodiment for loading a suture using a
suture cassette. In FIG. 19A, a cassette 1950 stores one suture
1960 and has two access ports providing access to suture ends 1965,
1975. In FIG. 19B, handle 1900 has a cassette insert port 1925
configured to receive suture cassette 1905 and position exposed
suture ends 1965, 1975 within needle tracks 150, 155 internally
within handle 1900 for eventual loading onto a suture passer in
preparation for deploying the sutures.
In an embodiment, slider 115 is spring-loaded to compress the
tissue to be sutured upon pressing control button 130. Thus, in the
embodiment, pressing control button 130 may cause two actions.
First, catcher 110 may be deployed, and second, slider 115 may be
forced to move distally--toward catcher 115. These actions may be
accomplished with a spring that is loaded as the slider moves
proximally--away from catcher 110. The spring may have a trigger
that is actuated by the final stage of the button stroke so that
pressing control button 130 first opens catcher 110 and, as control
button 130 is pressed an arbitrary further amount, the trigger
actuates to release the spring, which then pushes slider 115
against the skin, sandwiching the tissue between slider 115 and
catcher 110.
FIGS. 20A-20C depict an embodiment in which wings are flexible
sections of catcher struts and assist with capturing a suture. FIG.
20A depicts struts 912, 914, 916, 918 with sections similar in
dimension and stiffness to struts 112, 114, 312, 314 (FIG. 3).
Struts 912, 914, 916, 918 have flexible wings 1905, 1910, 1915,
1920. FIG. 20B depicts flexible wings 1905, 1910 being folded
within catcher 110 as it is retracted. When catcher 110 is
deployed, wings 1905, 1910, 1915, 1920 open to their intended
positions, and wing pairs 912, 916 and 914, 918 open and overlap,
presenting a target area for a suture as in FIG. 20A. In the
embodiment, the target area presented by the overlapping wing pairs
is a plane similar to that presented by membranes 302, 305 (FIG.
3), yet 1905, 1910, 1915, 1920 do not rely on tension for support
and, thus, they may be configured to extend beyond an area defined
by struts 912, 914, 916, 918. Wings 1905, 1910, 1915, 1920 may
assist capturing a suture end by being punctured, similarly to
membranes 302, 305, or they may assist capturing a suture by
allowing suture passer 200 to pass through seams 1925, 1930 between
the wing pairs. Once suture passer 200 passes through seams 1925,
1930, releases the suture, and is withdrawn, the wing pair 1905,
1915 or 1910, 1920 closes about and captures the deployed suture.
The captured suture ends may then be drawn in by the wing pair when
catcher 110 is retracted (FIG. 20C) and more firmly grasped by the
strut pair 912, 916 or 914, 918.
FIGS. 21A-21E depict embodiments allowing multiple uses of a
catcher membrane by varying the location that a catcher membrane is
penetrated. Generally, each insertion of needle through a membrane
creates and leaves a footprint on the membrane. With multiple
needle insertion, the holes created in the membrane may reduce the
membrane's ability to capture and retain subsequent sutures.
Embodiments provide for multiple uses of the same device by
changing the area penetrated by the suture passer for each use. The
suture catcher may be rotated so that the intended membrane area
for needle penetration is (sufficiently) different every time. The
rotation may be large angle or small angle depending on the
intended number of needle penetrations and allowable repeated
needle penetrations. Other embodiments reduce the probability of a
needle penetrating in the same area repeatedly by, e.g., providing
a random rotation of the suture catcher.
FIGS. 21A and 21B depict an embodiment of a multi-use catcher with
a random rotation mechanism. In this embodiment, the struts of the
catcher may pivot within a defined distance relative to the handle
shaft. A membrane attached to the struts may pivot with them. In
FIG. 21A, a single strut 2010 is pictured for clarity, but the
following description applies to the other struts of a catcher.
Catcher strut 2010 is free to pivot about an angle 2015 within a
window 2020 in shaft 2005. The size of window 2020 may define how
much catcher strut 2010 can rotate. Window 2020 may be provided in
a proximal part (e.g., proximal connection part 1115 (FIG. 11) for
each strut of a catcher, allowing each individual strut to move
freely within the windows. The connection between the distal joint
and the control rod may be floating such that rotation of the
proximal joint will result in rotation of the whole catcher. The
random rotation of the catcher allowed in this embodiment reduces
the probability that two needles will penetrate the membrane
precisely at the same location. FIG. 21B depicts a puncture pattern
on a membrane that may result from the rotation of a catcher
equipped with struts as in FIG. 21A. In FIG. 21B, membrane 2025
shows punctures 2030a, 2030b, 2030c that may result from the use of
suture passer within a single needle track, e.g., needle track 155
(FIG. 3), as the catcher and membrane are rotated within angle
2015.
FIG. 21C depicts an embodiment of a multi-use catcher with a needle
track with an internal pivot point. Needle track 2105 may be
greater in diameter than a needle or suture passer between
insertion point 2110 and a narrowing 2120 and between an exit point
2115 and the narrowing 2120. Narrowing 2120 may be a constriction
of needle track 2105, or simply a bump, at some position within
needle track 2105 that functions as a pivot point. With the needle
or suture passer being able to move radially within needle track
2105, narrowing 2120 may function as a pivot point to facilitate
moving the distal end of the needle or suture passer with respect
to the surface of a suture catcher 2135 by moving the proximal end
of the needle or suture passer, as depicted by exemplary suture
passer positions 2125, 2130. Suture passer positions 2125, 2130
show that, per the embodiment, a suture passer may exit needle
track 2105 at various angles relative to shaft 2140 and suture
catcher 2135. The changing angles reduce the probability that the
needle will penetrate a membrane on suture catcher 2135 at
precisely at the same location. In an embodiment, needle track 2105
may be hourglass shaped. In a further embodiment, needle track 2105
may not have narrowing 2120, but still allow for exemplary suture
passer positions 2125, 2130 by being generally larger in diameter
than the needle or suture passer.
FIG. 21D depicts a top view of a handle 2200 that provides for
multiple uses of a catcher membrane. In FIG. 21D, multiple needle
track pairs 2205a and b, 2210a and b, and 2215a and b, each target
different respective areas (not shown) of a membrane. In addition,
a dial feature (not shown) may rotate atop handle 2200 to expose
one set of needle tracks at a time.
FIG. 21E depicts a cross-section of a multi-use embodiment
employing an automatic pen rotation mechanism. Rotation of the
suture catcher may ensure that a needle or suture passer penetrates
a membrane at an unused location of the membrane. In the
embodiment, an automatic pen rotation mechanism 2300, or a
variation, may be used to achieve this. Mechanism 2300 contains
features that transfer up and down movement of control rod 2305
into a rotational movement of control rod 2305. With control rod
2305 connected to the distal joint of the suture catcher so that
rotation of control rod 2305 results in rotation of the distal
joint, and with the proximal joint of the suture catcher allowing
rotational movement of the suture catcher, the rotation of control
rod 2305 will result in the rotation of the suture catcher. The
magnitude of the resulting rotation is controlled per the design of
rotation mechanism 2300 and may be arbitrarily small or large. In a
variation of this embodiment, the up and down movement of control
rod 2305 results in a rotational movement of the proximal joint of
the suture catcher, the connection between the distal joint and the
control rod is floating, and the rotation of the proximal joint
results in the rotation of the whole suture catcher.
Embodiments may employ a suture passer with a tip designed to
receive sutures that are pre-loaded on the handle (see, e.g., FIGS.
18A and 18B and related text regarding loading sutures on the
handle). In such embodiments, the tip of the suture passer
preferably is able to: grasp the suture ends before entering the
abdominal tissues; retain the suture ends while penetrating the
tissue to be sutured and a catcher membrane, if the catcher is so
equipped; and deploy the suture ends.
FIGS. 22A-22D depict different embodiments of suture passers
designed to grasp, retain, and deploy a suture. In FIG. 22A, suture
passer 2400 has a fixed tip 2405 with a slot 2410 configured to
engage a suture 2415 positioned at an exit 2420 of a needle track
2425. In FIG. 22B, suture passer 2430 has an actuated tip 2435 with
a clamping member 2440 for clamping a suture 2445 against a fixed
member 2450 at the urging of an apparatus 2455, e.g., a driving
axle, internal to suture passer 2430. In FIG. 22C, suture passer
2460 has a grasping tip 2465 with a needle head 2470 actuated by an
internal rod 2475 for grasping a suture 2480 against a needle tube
2485. FIG. 22D depicts the grasping tip of suture passer 200
previously described with reference to FIGS. 2A and 2B for
comparison. This embodiment of a suture passer may also be used to
receive sutures that are pre-loaded on the handle. Similarly, the
embodiments of suture passers in FIGS. 22A-22C may be loaded with a
suture before being inserted into a needle track of a handle. In
embodiments, any of the needle tip embodiments disclosed may be
configured to cooperate with any of the needle tracks
disclosed.
In an embodiment of a procedure for deploying a suture loaded on a
handle, after the tissue to be sutured is sandwiched by a handle
(see, e.g., FIG. 8B), the suture passer is inserted into and
through the needle track until the tip reaches the suture loaded on
the handle. The suture is then loaded onto the suture passer. Then
the suture passer is inserted through the needle track to deploy
the suture end on the catcher. Depending on the catcher
configuration, the suture end may be deployed by being released
within grasping distance of catcher struts, or may be deployed by
being inserted into a catcher membrane and then released. After the
suture is released, the suture passer may be withdrawn and inserted
into a second needle track with the above procedure repeated with a
second suture loaded on the handle.
FIGS. 23A and 23B depict a cross-section of an embodiment in which
suture passers are integrated into a handle 2500. In FIG. 23A
suture passers 2505, 2510 are situated within needle tracks 2515,
2520, respectively, and used to deploy sutures. Suture passers
2505, 2510 may be designed to reside within needle tracks 2515,
2520. Control button 2540 (or control lever, or control slider)
may, upon actuation, cause suture passers 2505, 2510 to travel
through needle tracks 2515, 2520, grasp the loaded sutures, extend
from shaft 105 of handle 2500, and penetrate the tissue to be
sutured, e.g., the abdominal tissues. Suture passers 2505, 2510 may
then deploy the suture onto catcher 110.
In the embodiment, suture passers 2505, 2510 may be deployed using
a roller and track 2545 and control button 2540 to advance the two
suture passers through needle tracks 2515, 2520 to deploy the
sutures. Roller and track 2545 may include rollers 2550 within a
track 2555 connected to actuating arms 2560. Control button 2540
when pressed may cause roller and track 2545 and actuating arms
2560 to travel toward a distal end 2525 of handle 2500. Actuating
arms 2560 then force suture passers 2505, 2510 through needle
tracks 2515, 2520 to deploy the sutures. Roller and track 2545 are
configured to allow actuating arms 2560 to move inwardly within
handle 2500 as arms 2560 travel in the distal direction. In FIG.
23B, control button 2540 has been completely depressed, forcing
suture passers 2505, 2510 to extend past catcher 110, open suture
passer tips (see, e.g., FIGS. 22B-D), and deposit the sutures (not
shown). The motion of control button 2540 has revealed control
button 130, which as described earlier controls catcher 110 and
perhaps also slider 115. The motion has also caused rollers 2550 to
move inwardly within track 2555 in response to actuating arms 2560
following the contour of needle tracks 2515, 2520. In an
embodiment, the functions of control buttons 130 and 2540 are
performed by a single control button.
The embodiments of the suture delivery devices may be used to
practice the methods for inserting and withdrawing a suture passer,
and for capturing, retaining, and securing a suture. In
embodiments, membrane properties influence capturing, retaining,
and securing a suture. As described, when a needle or suture passer
carrying a suture is inserted through a membrane, a suture may be
released and captured by the membrane. When the catcher is then
closed, the membrane may fold with the catcher frame closure,
retaining the suture within the membrane. The membrane itself may
be made of a material with a high coefficient of friction or
further having designs that increase the suture-retaining
properties of the membrane. The retentive property may be a
function of the material thickness, or of the number of material
layers, or of the material surface. The retentive property may be
on either or both sides of the retaining surface.
In embodiments, a suture may be secured by catcher strut edges. A
number of methods may be employed (separately or in combination) to
ensure that a suture is secured to the distal end of the device.
Mechanical clamping of the suture may be used to retain the suture
during the withdrawal of the suture delivery device from the
surgical opening. Edges of adjacent struts may be used to hold a
suture securely (as a mechanical clamp). For embodiments in which a
suture catcher is equipped with a membrane, the membrane retention
force may not be sufficient to withstand the force exerted by the
sutured tissue on the suture, even if the suture is properly
engaged with the membrane. Thus, adjacent catcher struts may be
used as a clamp to secure a suture. Such adjacent struts may be
used independently (e.g., in catcher embodiments that do not
include a membrane), or may be used in combination with a membrane
(e.g., in catcher embodiments that include a membrane).
FIGS. 24A-24E depict embodiments of catchers that vary the length
of a clamping surface, or the number of clamping surfaces, or
number of contact points. In FIG. 24A, strut edges 2605, 2610 of
struts 2620 have been angled to increase the contact surface with
suture 2615. That is, the edges of catcher frame struts have been
beveled and the suture is in contact with the strut for the length
of the beveled edges. In FIG. 24B, struts 2625, 2630 are configured
to create a single contact point 2635 against suture 2615. In FIG.
24C, struts 2640 are sized differently from struts 2650. Suture
2615 is clamped between the surfaces of a pair of differently sized
struts 2640, 2650. In FIG. 24D, strut edges 2655, 2660 engage,
creating an angle in suture contact surface 2665. The angle may be,
e.g., 90 degrees. The catcher struts may also have saw tooth or
wavy edges along the suture contacting edges. The advantage of
designs with such edges is that the direction of the force applied
to the suture is changed, increasing the normal force at points
along the suture. In FIG. 24E, struts 2670 are added to the
configuration of FIG. 24B, creating additional suture contact
points 2637.
In embodiments, in addition to various strut designs just
discussed, the strut edges may be roughened, treated, coated, or
otherwise processed to increase friction and enhance
suture-securing performance. For example, rubber pads or strips, or
a rubber coating may be applied to the strut edges.
In alternate embodiments of a catcher, the suture may be clamped
between a catcher strut folding inwardly against the control rod,
or against a block positioned about the control rod that presents a
flat surface to the strut as the strut folds inward. In such
embodiments, both the membrane and the suture may be clamped
between an exterior element (the strut) and an interior element
(either the control rod, or the block about the control rod). Since
the effectiveness of clamping a suture may be associated with the
sufficient (or complete) closure of the suture catcher, the level
of the applied closing force and any interference caused by the
membrane may affect clamping effectiveness.
In the various embodiments of a suture catcher, increasing the
strut closing force may increase the retaining force on the suture.
As a result, the catcher may retain the suture during a more
forcible extraction of the suture delivery device from a surgical
opening.
In embodiments, the suture may be retained by the catcher without a
capture surface, e.g., a membrane. In such embodiments, the struts
of the catcher may directly clamp the suture. The clamping action
may, for example, be a part of the catcher being retracted for
extraction from the surgical opening.
FIGS. 25-27 depict further embodiments for delivering and catching
a suture. FIGS. 25A, 25B, and 26 depict embodiments for capturing a
suture on one side of a surgical opening and moving the suture to
the other side for completing the suture. FIGS. 25A and 25B depict
top and perspective views, respectively, of a clamping apparatus
2700 with clamping arms 2705, 2710 that pivot in directions 2707,
2712, respectively, to capture a suture end 2720. Clamping arm 2705
may be rotated by inner shaft 2725 and clamping arm 2710 may be
rotated by outer shaft 2730. Clamping apparatus 2700 may be
substituted for catcher 110 on handle 100 of, e.g., FIGS. 1A and
1B. Clamping apparatus 2700 may be used to capture suture 2720 and
position on an opposite side of clamping apparatus 2700 within a
surgical opening.
FIG. 26 depicts a perspective view of a capture apparatus 2800 with
a large area membrane 2805 supported by struts 2810 that pivot
about a shaft 2815 to deposit a captured suture 2820 on an opposite
side of capture apparatus 2800. Suture 2820 may be captured by
membrane 2805 as discussed previously. Capture apparatus 2800 may
also be substituted for catcher 110 on handle 100 of; e.g., FIGS.
1A and 1B.
An embodiment may include an umbrella-shaped membrane, where the
membrane is supported by several radially expanding struts and
spans 360 degrees around the device. Like an umbrella, the membrane
may be in tension, making it easier for a needle to penetrate the
membrane material. Also, the friction between the membrane material
and the suture may be enough to disengage and retain the suture as
the suture passer is withdrawn. Alternate embodiments may include
multi-layer membranes where each layer has different orientation.
In such a multi-layer membrane, the suture may be disengaged from
the suture passer due to both friction and becoming entangled in
the lattice structure.
The embodiments depicted by FIGS. 25A, 25B, and 26, may be used
according to the following method. The needle (or suture passer)
carrying a suture is inserted into a needle track and then into the
muscle/fascia layers on one-side of trocar wound using a handle
equipped with either clamping apparatus 2700 or capture apparatus
2800. The suture passer releases the suture and is withdrawn. For
clamping apparatus 2700, the suture is then captured by the motion
of clamping arms 2705, 2710. For capture apparatus 2800, the suture
has penetrated membrane 2805, which has material properties or
designs to disengage the suture from the needle passer and retain
it. Once the suture is retained, the suture may be moved by
rotating apparatus 2700 or 2800 causing suture 2720 or 2820 to be
repositioned to the opposite side of the trocar wound. The surgeon
may then easily retrieve the suture, since the suture is positioned
at the target point of a needle (or suture passer) inserted through
the other needle track of the handle and through the tissue to be
sutured. Once through the tissue to be sutured the needle (or
suture passer) may capture the repositioned suture with guidance
from a laparoscopic image. The captured suture may have a
controlled shape, orientation, and tension that would facilitate
the surgeon retrieving it. These embodiments, like previous
embodiments, remove the need for an assistant to help move the
suture to where the surgeon can grasp the suture with suture
passer.
FIG. 27 depicts a top view of an embodiment for linking suture ends
within a surgical opening. In FIG. 27, clamping apparatus 2900 has
clamping arms 2905, 2910 that pivot in directions 2907, 2912,
respectively, to sweep through an arc and capture suture ends 2920,
2922. Clamping arm 2905 may be rotated by inner shaft 2925 and
clamping arm 2910 may be rotated by outer shaft 2930 (alternately,
only one clamping arm is rotated to capture both suture ends).
Clamping apparatus 2900 may be substituted for catcher 110 on
handle 100 of, e.g., FIGS. 1A and 1B. Clamping apparatus 2900 may
be used to capture suture ends 2920, 2922 and link them together
with a link element 2935. Link element 2935 may be a crimp or
biodegradable member affixed to one of clamping arms 2905, 2910. It
may also be a clamp or clip. Additionally, suture ends 2920, 2922
may be linked using adhesive or heat, etc. The resulting suture
linkage should be at least strong enough to sustain pulling the
suture joint through the tissue track created by the needle or
suture passer. Alternately, the suture linkage should be strong
enough to provide wound closure.
Clamping apparatus 2900 may be used according to the following
method. The sweepers or clamp arms are initially positioned not to
interfere with suture delivery. Two suture ends are delivered on
opposite sides of a trocar wound. The clamp arms are then rotated
to bring the suture ends into contact with the link element. The
suture ends and the link element are then pressed together by the
clamp arms to link the suture. The suture delivery device may then
be withdrawn.
With this embodiment, one option for finishing a suture involves
delivering two ends of one suture. Once the two sutures ends are
linked, the linked suture becomes a loop. The user may cut the
suture at the proximal end--outside of the trocar wound. Then the
user may pull the external suture ends to close the wound, and then
knot the ends. Alternatively, the user could pull the suture link
out through the surgical opening with the suture delivery device,
or tug on one side of the suture loop to bring the link out through
the tissue track created by the initial needle insertion. The user
may then cut the suture joint, close the surgical opening and tie
the knot. Another option is to deliver two suture ends into the
abdomen, each end from a separate suture. Once the two sutures ends
are linked, the user could withdraw the device and finish the
suture as described above.
In an embodiment, a catcher closure mechanism is slider activated.
A suture delivery device may have a sliding member, which can be
positioned to sandwich abdominal wall tissue against a counterforce
member (e.g., a catcher), in the abdominal cavity. Many of the
embodiments described are configured this way. In this embodiment,
the sliding member may be coupled to the catcher deployment
mechanism so that movement of sliding member may be used to control
the catcher opening and closing. With the sliding member coupled to
the deployment mechanism, as the sliding member moves downward
(towards the distal end of device), the catcher deployment
mechanism may be actuated to open the catcher. When the sliding
member moves upward (towards the proximal end of the device), the
catcher deployment mechanism may be actuated to close the catcher.
The position where the sliding member interacts with the catcher
deployment mechanism may be designed as desired. In one embodiment,
the catcher may be opened when the sliding member travels a small
distance downward while the catcher may be closed when the sliding
member travels a small distance upward. For example, moving the
slider downwards may cause the distal joint to move upwards and
thereby deploy the suture catcher. Various mechanism options may be
used to enable this concept.
A method for using an embodiment may include: inserting a suture
delivery device through a tissue track until a distal end is inside
a cavity; moving a sliding member towards a device distal end to
open a catcher and then sandwich the abdominal wall tissue between
the catcher and the sliding member; delivering a suture to the
suture retention element (catcher) by inserting a suture-carrying
needle into the device until suture is released and retained at the
distal end (or until the suture is released and captured by the
catcher); moving the sliding member towards the proximal end of
device to close the catcher and release the abdominal wall tissue;
and withdrawing the suture delivery device from the cavity with the
suture ends retained at the device's distal end.
A method for automatically deploying a suture may include:
inserting a suture delivery device into a surgical opening;
sandwiching the wound tissue; deploying the suture ends, and
withdrawing the handle. Sandwiching the wound tissue may further
include: pressing a button that causes the catcher to open and the
slider to compress the tissue against the catcher. Deploying the
suture ends may further include: using an independent suture
passer, or using a suture passer that is integrated with the
handle. Withdrawing the handle may further include: closing the
catcher to capture sutures, and an automatic suture release.
A method for deploying a suture may include: loading a suture onto
a handle, or loading a suture cassette into a handle; with a left
hand, removing a trocar; with a right hand, inserting the handle
into the trocar wound until the catcher is completely visible from
a laparoscope image; with the right hand, releasing a control
button that opens the catcher and then pushes the slider down to
sandwich the tissue under visual guidance. The laparoscope image
may be used to show whether the catcher is in contact with the
peritoneum wall. In an embodiment, this method for deploying a
suture optionally includes: with the left hand, holding the handle;
with the right hand, inserting the suture passer through the needle
track to deploy suture on the catcher under visual guidance; and
repeating this with the other needle track under visual guidance.
In another embodiment, this method for deploying a suture
optionally includes: using the left hand, holding the handle; using
the right hand, pushing a deployment button to deploy a suture on
the catcher under visual guidance; using the left thumb, pressing
the control button to capture the sutures under visual guidance;
and using the left hand, pulling out the handle and harvesting the
two suture ends.
Described herein are certain exemplary embodiments. However, one
skilled in the art that pertains to the present embodiments will
understand that the principles of this disclosure can be extended
easily with appropriate modifications to other applications.
* * * * *